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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032626
Receipt No. R000037201
Scientific Title Effect of skin cleansing foam on skin condition
Date of disclosure of the study information 2018/05/18
Last modified on 2018/05/17

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Basic information
Public title Effect of skin cleansing foam on skin condition
Acronym Effect of skin cleansing foam on skin condition
Scientific Title Effect of skin cleansing foam on skin condition
Scientific Title:Acronym Effect of skin cleansing foam on skin condition
Region
Japan

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate changes in skin condition when an adult female uses cleansing foam for 4 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of skin condition before starting use of test article and 4 weeks after use, comparison of skin condition of test group use group and placebo use group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Using cleansing foam for 4 consecutive weeks
Interventions/Control_2 4 weeks use of facial cleansing foam with a shape similar to the specimen generally sold
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria 1. Female between 30 and 60 years of age inclusive
2. Subjects who care about the condition of the skin from day to day
Key exclusion criteria 1. Subjects with cosmetic allergies
2. Subjects who are pregnant or lactating
3. Subjects with inflamed or scraped skin on face
4. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization RISOU Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037201

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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